22598 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices 

Dated: April 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–9902 Filed 4–28–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0034] 

Agency Information Collection 

Activities; Submission for Office and 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on How to Submit a Notice of 

Final Disposition of Investigational 

Animals Not Intended for Immediate 

Slaughter in Electronic Format to the 

Center for Veterinary Medicine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 1, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0453. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on How to 

Submit a Notice of Final Disposition of 

Investigational Animals Not Intended 

for Immediate Slaughter in Electronic 

Format to the Center for Veterinary 

Medicine—(OMB Control Number 

0910–0453)—Extension 

The Center for Veterinary Medicine 

(CVM) monitors the final disposition of 

investigational animals where such 

animals do not enter the human food 

chain immediately at the completion of 

an investigational study. CVM’s 

monitoring of the final disposition of 

investigational food animals is intended 

to ensure that unsafe residues of new 

animal drugs do not get into the food 

supply. CVM issues a slaughter 

authorization letter to investigational 

new animal drug (INAD) sponsors that 

sets the terms under which 

investigational animals may be 

slaughtered (21 CFR 511.1(b)(5)). Also 

in the letter, CVM requests that sponsors 

submit a notice of final disposition of 

investigational animals (NFDA) not 

intended for immediate slaughter. 

NFDAs have historically been submitted 

to CVM on paper. CVM’s guidance 

entitled ‘‘How to Submit a Notice of 

Final Disposition of Investigational 

Animals not Intended for Immediate 

Slaughter in Electronic Format to CVM’’ 

provides sponsors with an option to 

submit an NFDA as an e-mail 

attachment to CVM via the Internet. 

The likely respondents are INAD 

sponsors. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

Form No. 3487 

Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 2

Hours per 

Response Total Hours 

511.1(b)(5) 40 0 .4 16 .08 1 .3 

1There are no capital or operating and maintenance costs associated with this collection of information. 

2Electronic submissions received between January 1, 2008, and December 31, 2008. 

The number of respondents in table 1 

of this document are the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between January 1, 

2008, and December 31, 2008. Thus, 

FDA estimates the total reporting 

burden at 1.3 hours (16 x .08= 1.3 total 

hours). 

Dated: April 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–9901 Filed 4–28–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0055] 

Agency Information Collection 

Activities; Submission for Office and 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on How to Submit a Protocol 

Without Data in Electronic Format to 

the Center for Veterinary Medicine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 1, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0524. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices 22599 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on How to 

Submit a Protocol Without Data in 

Electronic Format to the Center for 

Veterinary Medicine—(OMB Control 

Number 0910–0524)—Extension 

Protocols for nonclinical laboratory 

studies (safety studies), are required 

under 21 CFR 58.120 for approval of 

new animal drugs. Protocols for 

adequate and well-controlled 

effectiveness studies are required under 

21 CFR 514.117(b). Upon request by the 

animal drug sponsors, the Center for 

Veterinary Medicine (CVM) reviews 

protocols for safety and effectiveness 

studies for which CVM and the sponsor 

consider this to be an essential part of 

the basis for making the decision to 

approve or not approve an animal drug 

application or supplemental animal 

drug application. The establishment of a 

process for acceptance of the electronic 

submission of protocols for studies 

conducted by sponsors in support of 

new animal drug applications, is part of 

CVM’s ongoing initiative to provide a 

method for paperless submissions. 

Sponsors may submit protocols to CVM 

in paper format. CVM’s guidance on 

how to submit a study protocol permits 

sponsors to submit a protocol without 

data as an e-mail attachment via the 

Internet. Further, this guidance also 

electronically implements provisions of 

the Government Paperwork Elimination 

Act (GPEA). The GPEA required Federal 

agencies, by October 21, 2003, to 

provide the following: (1) The option of 

the electronic maintenance, submission, 

or disclosure of information, if 

practicable, as a substitution for paper 

and (2) the use and acceptance of 

electronic signatures, where applicable. 

FDA Form 3536 is used to facilitate the 

use of electronic submission of 

protocols. This collection of information 

is for the benefit of animal drug 

sponsors, giving them the flexibility to 

submit data for review via the Internet. 

The likely respondents are sponsors 

of new animal drug applications. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

Form No. 3536 

Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 2

Hours per 

Response Total Hours 

514.117(b) & 58.120 40 1 .8 72 20 14 .4 

1There are no capital or operating and maintenance costs associated with this collection of information. 

2Electronic submissions received between January 1, 2008, and December 31, 2008. 

The number of respondents in table 1 

of this document is the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between January 1, 

2008, and December 31, 2008, (72 x 

hours per response (.20) = 14.4 total 

hours)). 

Dated: April 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10023 Filed 4–28–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0153] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Food 

and Drug Administration and Industry 

Procedures for Section 513(g) 

Requests for Information Under the 

Federal Food, Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Draft Guidance for Industry 

and FDA Staff; FDA and Industry 

Procedures for Section 513(g) Requests 

for Information Under the Federal Food, 

Drug, and Cosmetic Act.’’ This draft 

guidance is not final nor is it in effect 

at this time. Elsewhere in this issue of 

the Federal Register, FDA is also 

publishing a notice of availability for a 

draft guidance entitled ‘‘Draft Guidance 

for Industry and FDA Staff; User Fees 

for 513(g) Requests for Information.’’ 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on this 

draft guidance by July 28, 2010. Submit 

written or electronic comments on the 

collection of information by June 28, 

2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

requests for single copies of the draft 

guidance document entitled ‘‘Draft 

Guidance for Industry and FDA Staff; 

FDA and Industry Procedures for 

Section 513(g) Requests for Information 

Under the Federal Food, Drug, and 

Cosmetic Act’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002, or to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The draft 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax your 

request to CDRH to 301–847–8149. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance. 

Submit written comments concerning 

this draft guidance and the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Heather S. Rosecrans, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm., 1532, Silver Spring, 

MD 20993–0002, 301–796–6571, or 

Steve Ripley, Center for Biologics 

Evaluation and Research, (HFM–17), 

mstockstill on DSKH9S0YB1PROD with NOTICES